FDA applicant
Canon Medical Systems Corporation
FDA records 97 decisions for Canon Medical Systems Corporation (Otawara-Shi, JP) from 2018 to 2026: 97 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 110 predicates, 77 of them its own earlier devices. 28 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Canon Medical Systems Corporation’s devices, and how often a recall has named them.
FDA decisions per year
9in 2025
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Canon Medical Systems Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Canon”
FDA records each applicant name separately; these may or may not be the same firm.